Training and Educational Resources
Education and tools for conducting thoughtful and rigorous protocol reviews.
The MCW HRPP is committed to providing IRB Members with the education and tools necessary to conduct thoughtful and rigorous reviews of human research protocols that come before the MCW IRB Committees. Therefore the MCW HRPP provides various educational opportunities to assist with building knowledge and competence over time. These opportunities include continuing education presentations during the IRB meetings, monthly research education presentations at MCW for the research community, and completion of CITI training.
Links to various Human Subject Research regulations and other resources.
- Criteria for Approval (PDF): The eight regulatory criteria which must be met for IRB approval
- HHS Exempt Research Criteria: Regulatory criteria and types of activities which may qualify for exempt determination
- HHS Expedited Review Criteria: Criteria and types of activities which qualify for expedited review
- HHS Elements of Informed Consent: The general requirements and additional elements for informed consent when conducting human subject research
- HIPAA Regulations and Human Subject Research: Overview of HIPAA regulations and their impacts when conducting human subject research
Training and Educational Resources
The MCW HRPP provides various educational opportunities to assist with building knowledge and competence over time. These resources may be accessed by both new IRB Members and current Members.
New IRB Members are required to complete initial CITI training which includes modules covering the history and purpose of IRB regulations, ethical principles related to human subject research, and regulations apply to studies enrolling certain vulnerable populations and to various types of studies.
The initial course can be completed in four to six hours.
All IRB Members are required to maintain on-going human subjects research protections training via CITI.
In order to maintain CITI certification, a refresher course must be completed every three years. The refresher course can usually be completed in less than two hours.
How to complete CITI training:
Register with CITI
- Choose the Medical College of Wisconsin as your institution (even if your home institution is Froedtert Hospital, Children’s Hospital of Wisconsin, or BloodCenter of Wisconsin).
- On the Main Page, choose Group 3 to begin the course.
- Complete the required modules and associated quizzes. You may re-review the modules and repeat any quizzes to attain the overall passing score of 80%.
- Upon successful completion of the modules and quizzes, print a copy of your completion report (either paper or PDF) and send a copy to the MCW IRB Office for their records or bring a copy to the IRB Committee meeting.
The IRB Committees review a variety of topics on a monthly basis. These continuing education moments are discussed along side a PowerPoint presentation. Please find below the topics reviewed in recent meetings:
- IRB Approval Criteria
- Navigating a Convened Meeting
- Subtleties of Tabling
- Review of Devices
- Conduct & Expectations of IRB Members
- Primary Reviewer Responsibilities
- Continuing Reviews
Since 2016, IRB member may now claim 1 hour CME/CE credits for their attendance and participation as an IRB member of the MCW IRB committees. Credits can only be claimed by logging into the Ethos CE system. If you have questions about this process, contact the MCW IRB Office
Research Systems Training offers eBridge System training for new and existing committee members.
The one-hour session is scheduled on an as-needed-basis.
The training session provides a hands-on opportunity to navigate within eBridge as an IRB Committee Member and demonstrates the IRB Reviewer process.
Criteria for Approval
- Criteria for Approval (PDF)
- Criteria for Exempt Determination
- Criteria for projects which qualify for Expedited Review
Informed Consent Requirements
- Informed consent-basic elements and additional elements (45 CFR 46.116)
- Criteria for Waiver of Informed Consent Procedure (PDF)
- Criteria for Waiver of Informed Consent Documentation (PDF)
Criteria to grant a waiver of HIPAA authorization
New IRB Committee Members are invited to a meeting or series of meetings that provide an orientation to the IRB review process. The topics presented include
- Oversight Issues for IRBs
- Types of IRB Review
- Continuing Review
- Key components of 45 CFR 46 as applied to the review of research, initial and continuing
- FDA regulations that apply to human subject research
- HIPAA regulations that apply to human subject research
- Protected populations
- IRB Meetings and Record Keeping
- Informed consent: elements, documentation, waiver of consent, waiver of documentation
- Conflict of interest: PI and IRB Members
- Protocol Review and Presentation during an IRB Meeting